REACH requires EU companies manufacturing and importing chemicals to assess their chemicals and propose risk management measures. This assessment needs to be documented in a registration dossier which companies need to prepare and submit to ECHA. Information on properties and uses must be provided on all chemicals manufactured or imported in quantities of one tonne or more per year.Learn more
Dossier evaluation covers two processes:
Compliance checks verify that the submitted information fulfils the legal requirements under REACH. The requirements depend on the quantity of the substance that is manufactured or imported.Learn more
Possible outcomes of the compliance check
You can check the status of the evaluation of a dossier and see the adopted decisions on ECHA’s website.Learn more
Examination of testing proposals
Registrants must submit a testing proposal if they intend to perform a new test listed in Annexes IX and X to REACH.
The aim of testing proposal examination is mainly to avoid unnecessary animal testing, especially when the testing involves the use of vertebrate animals. Registrants need to receive ECHA’s decision before they can perform any testing.
ECHA evaluates all testing proposals made by registrants.
If the proposed test involves testing on vertebrate animals, registrants need to show that animal testing is used as a last resort and provide reasons why adaptations are not possible.
Adaptations to standard information requirements are listed in Column 2 of Annexes VII to X and in Annex XI to REACH.
Proposals to test on vertebrate animals are always published on ECHA’s website and opened for third party consultation.
ECHA prepares its draft decision based on the testing proposal made by the registrant and the information provided by third parties.
Possible outcomes of the testing proposal examination
ECHA addresses all third-party contributions in the dossier evaluation decisions.Learn more
The aim of substance evaluation is to clarify whether the use of a substance may cause harm to human health or to the environment. ECHA and the Member States authorities identify such substances of concern.
Together with the Member States, ECHA defines the risk-based criteria according to which substances are prioritised for evaluation and selects the substances to be included in the Community rolling action plan (CoRAP). Substances listed in the CoRAP are evaluated by the Member States. Only substances registered under REACH are subject to substance evaluation.
Each substance listed in the CoRAP is assigned to a Member State for evaluation. The evaluating Member State competent authority (eMSCA) of the substances scheduled for the first year, has 12 months from the publication of the CoRAP to evaluate whether further information is needed to clarify the identified concern.